Johnson & Johnson: RYBREVANT FASPRO shows high response in first‑line advanced head and neck cancer
- Cohort 5 (OrigAMI‑4) reported a 77% confirmed overall response rate in non‑HPV recurrent/metastatic HNSCC (22 patients), with 14% complete responses.
- Responses occurred at a median of 9.4 weeks and 65% remained ongoing at a median follow‑up of 10.6 months; median overall survival was not reached.
- Thirty patients received the regimen; 29 were evaluable for efficacy; HPV‑associated OPSCC subgroup (n=7) had ORR 29%.
- Most common adverse events were anemia (73%), hypoalbuminemia (63%), thrombocytopenia (63%) and stomatitis (57%); administration‑related reactions occurred in 13% with no Grade ≥3 events.
Trial and regimen
Cohort 5 of the Phase 1b/2 OrigAMI‑4 study evaluated subcutaneous RYBREVANT FASPRO (amivantamab and hyaluronidase‑lpuj) administered every three weeks in combination with pembrolizumab and up to six cycles of carboplatin in previously untreated, PD‑L1‑positive (CPS ≥1) recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). Administration time for the subcutaneous dose was five minutes or less. The primary endpoint was overall response rate (ORR) assessed by RECIST v1.1.
Efficacy results
Thirty patients received treatment and 29 were included in the efficacy analysis. Among 22 patients with HNSCC other than HPV‑associated oropharyngeal squamous cell carcinoma, confirmed ORR was 77% (95% CI, 55–92), including 14% complete responses and 64% partial responses. Responses occurred at a median of 9.4 weeks; 65% of responses were ongoing at a median follow‑up of 10.6 months. Median overall survival was not reached and 77% of patients were alive at one year. The seven patients with HPV‑associated OPSCC had an ORR of 29% (95% CI, 4–71).
Safety
The safety profile was reported as consistent with the individual agents. The most common adverse events were anemia (73%), hypoalbuminemia (63%), thrombocytopenia (63%) and stomatitis (57%). Administration‑related reactions to subcutaneous amivantamab occurred in 13% of patients with no Grade 3 or higher events reported.
Context and next steps
Johnson & Johnson said the results support the ongoing pivotal Phase 3 OrigAMI‑5 study and further clinical development of subcutaneous amivantamab in head and neck cancer. An application for RYBREVANT FASPRO in later‑line head and neck cancer is under Priority Review with the U.S. FDA.
Source: J&J